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Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia (MEL-QUE)

Primary Purpose

Psychiatric Disorders, Insomnia

Status

Recruiting

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Melatonin

Quetiapine

Placebo

About this trial

This is an interventional treatment trial for Psychiatric Disorders

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 to 65 years of age ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69) Self-reported sleep difficulties at least three times per week in the preceding 3 months Insomnia Severity Index score ≥11 Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures Informed consent Exclusion Criteria: Current treatment with melatonin or quetiapine Severe somatic comorbidity BMI ≥ 35 kg/m2 Breastfeeding Alcohol and/or substance dependency Inadequate Danish language skills Not able to make an informed consent Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline ECG

Sites / Locations

Mental Health Center CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Quetiapine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Insomnia severity

Insomnia Severity Index, range 0-28, higher is worse

Secondary Outcome Measures

Clinical global impression (CGI)

Clinical global impression: Severity, range 0-7, higher is worse

Subjective sleep quality

Pittsburgh Sleep Quality Index, range 0-21, higher is worse

Psychosocial functioning

Personal and Social Performance Scale, range 1-100, higher is better

Patient-reported subjective well-being

WHO-5 well-being index, range 0-100, higher is better

Full Information

NCT ID

NCT06062953

First Posted

September 13, 2023

Last Updated

September 25, 2023

Sponsor

Lone Baandrup

Collaborators

Danish Center for Sleep Medicine, Region Capital Denmark, Copenhagen Trial Unit, Center for Clinical Intervention Research, Mental Health Services in the Capital Region, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT06062953

Brief Title

Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia

Acronym

MEL-QUE

Official Title

Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 18, 2023 (Actual)

Primary Completion Date

February 28, 2026 (Anticipated)

Study Completion Date

February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lone Baandrup

Collaborators

Danish Center for Sleep Medicine, Region Capital Denmark, Copenhagen Trial Unit, Center for Clinical Intervention Research, Mental Health Services in the Capital Region, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are: To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia To examine how melatonin or low-dose quetiapine affects global symptom severity, sleep quality, psychosocial functioning and subjective well-being. Participants will receive six weeks of treatment with either melatonin, quetiapine or placebo followed by a brief taper off.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychiatric Disorders, Insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

255 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Melatonin

Arm Type

Experimental

Arm Title

Quetiapine

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Melatonin

Intervention Description

3-9 mg flexible dosing before bed time

Intervention Type

Drug

Intervention Name(s)

Quetiapine

Intervention Description

50-150 mg flexible dosing before bed time

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

1-3 capsules flexible dosing before bed time

Primary Outcome Measure Information:

Title

Insomnia severity

Description

Insomnia Severity Index, range 0-28, higher is worse

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Clinical global impression (CGI)

Description

Clinical global impression: Severity, range 0-7, higher is worse

Time Frame

6 weeks

Title

Subjective sleep quality

Description

Pittsburgh Sleep Quality Index, range 0-21, higher is worse

Time Frame

6 weeks

Title

Psychosocial functioning

Description

Personal and Social Performance Scale, range 1-100, higher is better

Time Frame

6 weeks

Title

Patient-reported subjective well-being

Description

WHO-5 well-being index, range 0-100, higher is better

Time Frame

6 weeks

Other Pre-specified Outcome Measures:

Title

Objective sleep quality (polysomnography)

Description

Total sleep time in minutes, higher is better

Time Frame

6 weeks

Title

Circadian rhythmicity (actigraphy)

Description

Interdaily stability which quantifies the invariability from day to day, i.e., the predictability of the 24 h rest-activity pattern. This index will be 1 for perfect interdaily stability and thus lower values reflect higher variability between the observed days

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lone Baandrup, MD

Phone

+4591165903

lone.baandrup@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lone Baandrup, MD

Organizational Affiliation

Mental Health Center Copenhagen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mental Health Center Copenhagen

City

Copenhagen NV

ZIP/Postal Code

2400

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ursula Brinck-Claussen, MD

Phone

+4520483136

ursula.oedum.brinck-claussen@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data will be available for meta-analysis. Proposals should be directed to: lone.baandrup@regionh.dk. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Time Frame

After publication of planned primary, secondary and exploratory outcomes. There will be no end date for availability of data.

IPD Sharing Access Criteria

Meta-analytical purposes

Learn more about this trial

Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia

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